-- The Company's lead product candidate is Azeliragon, under phase III trial in patients with mild Alzheimer's disease, dubbed STEADFAST.

The STEADFAST trial has 2 parts - Part A and Part B. Part A enrolled patients in the United States and Canada. Part B included study sites in the United Kingdom, Ireland, Australia, New Zealand and South Africa.

Top-line results from Part A of the study are expected to be in early 2018 and that from Part B in late 2018.

News: The Company announced updated results from a phase II study of Sacituzumab govitecan (IMMU-132) in patients with relapsed or refractory metastatic triple-negative breast cancer (mTNBC).

According to the updated results, in 110 patients with mTNBC after receiving treatment with Sacituzumab govitecanthe, the Objective Response Rate (ORR) is 31%, and median duration of response is 9.1 months. The clinical benefit rate at 6 months is 45%.

Near-term catalyst:

The Company remains on track to submit the Biologics License Application for accelerated approval of Sacituzumab Govitecan as 3rd line treatment for metastatic triple-negative breast cancer in Q1, 2018.

-- A phase III program evaluating INOpulse in the treatment of Pulmonary Arterial Hypertension, dubbed INOvation-1, is underway. Interim analysis and the top-line results for the study are expected to be available in 2018.-- A second phase III study of INOpulse in Pulmonary Arterial Hypertension, dubbed INOvation-RW, is planned for initiation in the second half of 2018, with top-line results anticipated in 2019.-- A phase IIb study for INOpulse in Idiopathic Pulmonary Fibrosis, called iNO-PF, is expected to commence in early 2018, with readout expected by the end of 2018.

-- On November 1, 2017, the Company reported financial results for the third quarter ended September 30, 2017, and also increased 2017 financial guidance.

For 2017, the Company now expects total revenue of $250.0 million to $255.0 million, adjusted net income of $63.0 million to $68.0 million, and adjusted EPS of $1.10 to $1.15. Previously, the Company had forecast total revenue to range between $220.0 million to $230.0 million; adjusted net income range of $56.0 million to $66.0 million, and adjusted EPS of $1.00 to $1.10.

Near-term catalyst:

The Company's supplemental New Drug Application for AMITIZA in children aged 6 to 17 years with pediatric functional constipation is under priority review by the FDA - with a decision date set for January 28, 2018.